Job Description
Join BioVita Pharmaceuticals, a global leader in innovative therapeutics, as we pioneer the next generation of medical breakthroughs. We're seeking a dynamic Senior Clinical Research Associate to oversee critical clinical trials, ensuring compliance with regulatory standards while advancing patient care. This hybrid role offers the opportunity to shape the future of medicine in a collaborative, research-driven environment.
Responsibilities
- Design and implement clinical trial protocols aligned with FDA/EMA guidelines
- Monitor trial sites for GCP compliance and data integrity
- Liaise with investigators to resolve protocol deviations and ensure patient safety
- Analyze clinical data and prepare regulatory submissions (IND/CTA)
- Mentor junior CRAs and optimize trial execution workflows
- Collaborate with cross-functional teams (biostatistics, medical affairs)
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience in Phase II-III trials
- Certified CRA (ACRP/SoCRA) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Strong knowledge of ICH-GCP and regulatory frameworks
- Exceptional problem-solving and stakeholder management skills